TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT— 510(k) K950514

Name: FDA 510(k) clearance K950514
Creator: U.S. Food and Drug Administration
Published: 1995-03-07

Substantially Equivalent

3M Unitek

FDA 510(k) clearance K950514 for TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT, Substantially Equivalent on 1995-03-07. Applicant: 3M Unitek. Device class: 2.

Clearance details

Applicant: 3M Unitek
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1995-02-06
Decision date: 1995-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.